(119 days)
The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.
The Yosomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the pen-injector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
Acceptance Criteria and Device Performance Study for Clickfine Pen Needle
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Standard/Regulation | Reported Device Performance |
|---|---|---|
| Pen-injector requirements (Needles) | ISO 11608-2:2000 | Met the requirements of relevant sections of the standard. |
| Stainless steel needle tubing | ISO 9626:1991/Amd.1:2001 | Met the requirements of relevant sections of the standard. |
| Sterile hypodermic needles for single use | ISO 7864:1993 | Met the requirements of relevant sections of the standard. |
| Biological evaluation of medical devices | ISO 10993-1:2003 | Met the requirements of relevant sections of the standard. |
| Puncture resistance of outer cap | Internal Protocol | Equivalent to Unmodified Device. |
| Seal Integrity of Sterile barrier | Internal Protocol | Equivalent to Unmodified Device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes used for each of the tests. The studies involved testing the Ypsomed Clickfine Pen Needles against various international and internal standards and protocols.
The data provenance is from Ypsomed AG, a company based in Switzerland, indicating that the testing was conducted by or under the supervision of the manufacturer. The studies are assumed to be prospective, as they were conducted to demonstrate compliance and equivalence for the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies were based on compliance with established international and internal standards, which typically have predefined objective criteria for evaluation rather than relying on expert consensus for ground truth on a case-by-case basis.
4. Adjudication Method for the Test Set
This information is not explicitly stated. Given that the acceptance criteria are based on compliance with international and internal standards, the adjudication would likely involve direct measurement and comparison against predefined thresholds or specifications outlined in those standards, rather than an expert adjudication method like 2+1 or 3+1.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a physical medical device (pen needle), and its performance evaluation focuses on physical, mechanical, and biological properties, not on interpretation by human readers.
6. If a Standalone Performance Study Was Done
Yes, standalone performance studies were done. The "Performance and Safety Data" section explicitly states that Ypsomed "performed the relevant assessments specified in the following international and internal standards and protocols and confirmed compliance of the modified devices and equivalence to the predicate devices." This implies that the device's performance was evaluated independently against established criteria in these standards.
7. The Type of Ground Truth Used
The ground truth used for these studies was based on the requirements and test methods specified in the cited international standards (ISO 11608-2, ISO 9626, ISO 7864, ISO 10993-1) and internal protocols. These standards define objective, measurable criteria for the performance, safety, and biological compatibility of pen needles. For example, "puncture resistance" and "seal integrity" would have quantifiable thresholds or specifications within these standards or internal protocols that the device's measurements needed to meet.
8. The Sample Size for the Training Set
This information is not applicable and is not provided. The Clickfine Pen Needle is a physical medical device, not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. The device is a physical medical device and does not utilize a training set in the way AI or machine learning models do.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).